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The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel

NCT07187674 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-23

No results posted yet for this study

Summary

Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend is younger. In 2022, the estimated number of new cases of female breast cancer worldwide is 2.389 million, and the estimated number of deaths is 666000. Triple negative breast cancer (TNBC) refers to breast cancer that is negative for estrogen receptor, progesterone receptor and human epidermal growth factor receptor 2, accounting for about 10% - 20% of malignant breast tumors. . At present, chemotherapy is still the main means of clinical treatment of TNBC, but the heterogeneity of TNBC in molecular level, pathology and clinical characteristics leads to different sensitivity of patients to different chemotherapeutic drugs, especially the sensitivity of most elderly patients to chemotherapeutic drugs is not high, and the prognosis is poor.

The development of immunotherapy in the field of breast cancer has witnessed the continuous deepening of medical understanding of cancer treatment. In the past, breast cancer was often regarded as a "cold tumor" insensitive to immunotherapy, but with the deepening of research, immunotherapy gradually occupied an important position in the treatment of breast cancer. The ongoing research hopes to identify patients who may benefit more from immunotherapy according to their respective tumor immune microenvironment.

Its mechanism of action mainly includes two aspects: one is to restore the normal recognition and attack ability of the immune system to tumor cells and break the immune escape mechanism of tumor cells; The second is to stimulate a lasting immune response, so that the immune system can continuously monitor and clear tumor cells.

Therefore, this study intends to evaluate the efficacy and safety of Iparomlimab and tuvonralimab combined with olaparib and paclitaxel in the neoadjuvant treatment of early high-risk TNBC with HRD positive.

It is planned to enroll 20 subjects. After enrollment, the subjects will receive six cycles of combination therapy with olaparib and docetaxel. Take 3 weeks as a treatment cycle until the treatment termination event specified in the protocol occurs, and the subject will continue to conduct postoperative efficacy and safety visits after the end of treatment.

After neoadjuvant treatment, according to the routine treatment process of breast cancer, the subject will receive breast cancer surgery; After surgical treatment, according to the residual breast lesions of the patient, the attending physician and the subject will agree on the subsequent treatment plan.

Conditions

  • Triple Negative Breast Cancer (TNBC)

Interventions

DRUG

Iparomlimab and tuvonralimab combined with olaparib and paclitaxel

The main objective of this study is to evaluate the tpCR of early high-risk TNBC with HRD positive treated with Iparomlimab and tuvonralimab combined with olaparib and paclitaxel as neoadjuvant therapy

Sponsors & Collaborators

  • Harbin Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2028-06-15
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187674 on ClinicalTrials.gov